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Clinical Study of AK101 in Subjects With Moderate to Severe Plaque Psoriasis

NCT04173637 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2025-02-28

No results posted yet for this study

Summary

This is a multiple-center, randomized, double-blind, placebo-controlled Phase IIb study to evaluate the efficacy and safety of AK101, an anti-IL-12/23 p40 antibody, when administered subcutaneously, in subjects with moderate-to-severe plaque psoriasis. The study will consist of 3 periods: up to 4 weeks screening, 12 weeks double-blinded treatment and long-term follow-up period(up to 52 weeks).

Conditions

Interventions

BIOLOGICAL

AK101

an anti-IL-12/23p40 monoclonal antibody

BIOLOGICAL

Placebo

matching placebo

Sponsors & Collaborators

  • Akeso Tiancheng, Inc

    collaborator OTHER

  • Akeso

    lead INDUSTRY

Principal Investigators

  • Jianzhong Zhang, MD · Peking University People's Hospital

  • Hongzhong Jin, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2022-03-03
Completion
2022-03-03

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04173637 on ClinicalTrials.gov